Genomics-based early-phase clinical trials in oncology: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies

Stephen V Liu; Vincent A Miller; Marinus W Lobbezoo; Giuseppe Giaccone

doi:10.1016/j.ejca.2014.07.027

Genomics-based early-phase clinical trials in oncology: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies

Eur J Cancer. 2014 Nov;50(16):2747-51. doi: 10.1016/j.ejca.2014.07.027. Epub 2014 Sep 15.

Authors

Stephen V Liu¹, Vincent A Miller², Marinus W Lobbezoo³, Giuseppe Giaccone¹

Affiliations

¹ Georgetown University, Washington, DC, USA.
² Foundation Medicine, Cambridge, MA, USA.
³ NDDO Education Foundation, Amsterdam, The Netherlands.

PMID: 25227487
DOI: 10.1016/j.ejca.2014.07.027

Abstract

The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force discussed incorporation of genomic profiling into early (Phase I and II) clinical trials in oncology. The task force reviewed the challenges of standardising genomics data in a manner conducive to conducting clinical trials. Current barriers to successful and efficient implementation were identified and discussed, as well as the methods of genomic analysis, the proper setting for study and strategies to facilitate timely completion of genomics-based studies. The importance of properly capturing and cataloguing outcomes was also discussed. Several recommendations regarding the use of genomics in these trials are provided.

Keywords: Clinical trials; Genomics; Phase I.

MeSH terms

Advisory Committees
Clinical Trials as Topic
Genome, Human
Genomics*
Humans
Maximum Tolerated Dose
Medical Oncology / methods*
Medical Oncology / organization & administration
Neoplasms / therapy*
Signal Transduction
Therapies, Investigational / methods
Treatment Outcome